JPS6411311B2 - - Google Patents

Info

Publication number
JPS6411311B2
JPS6411311B2 JP55104484A JP10448480A JPS6411311B2 JP S6411311 B2 JPS6411311 B2 JP S6411311B2 JP 55104484 A JP55104484 A JP 55104484A JP 10448480 A JP10448480 A JP 10448480A JP S6411311 B2 JPS6411311 B2 JP S6411311B2
Authority
JP
Japan
Prior art keywords
blade surface
inner needle
needle
tubular inner
curved
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
JP55104484A
Other languages
Japanese (ja)
Other versions
JPS5729366A (en
Inventor
Shoji Ookura
Koremasa Goshi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fuji Terumo Co Ltd
Original Assignee
Fuji Terumo Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fuji Terumo Co Ltd filed Critical Fuji Terumo Co Ltd
Priority to JP10448480A priority Critical patent/JPS5729366A/en
Publication of JPS5729366A publication Critical patent/JPS5729366A/en
Publication of JPS6411311B2 publication Critical patent/JPS6411311B2/ja
Granted legal-status Critical Current

Links

Description

〔留置針〕[Indwelling needle]

カテーテル11は、合成樹脂例えばエチレンテ
トラフルオロエチレン(ETFE)、フルオリネイ
テツドエチレンプロピレン(FEP)で出来てお
り、通常押出し成形で一体に成形される。このカ
テーテル11は、先端部11aの内径を小径と
し、かつ外径にはテーパをつけている。カテーテ
ルの内径は品種によつて異なるが、通常0.57〜
1.78mmφである。なおこのカテーテルの基端には
ハブ18が一体にとりつけられている。 一方金属内針12は、ステンレス鋼で筒状に形
成され、その先端に刃面形成部13が設けられ
て、この刃面形成部13には刃面13aがつけら
れる。刃面13aは、通常16〜20゜の傾斜面で、
更に刃面形成部13の刃面13aのうち、先端か
ら30〜70%の長さの個所においてその両側を削
り、先端を尖らせている。そして更に、この金属
内針12は、刃面形成部13の背面13bを中心
軸方向に折曲げられている。この折曲部14は、
刃面形成部13の先端がカテーテル11の内壁、
とくに先端部11aの内壁に接しないように設け
たもので、この点からすれば折曲げ角度(α)は
大きい程よいが、他方この針を使用時体内に挿入
する際の刺通抵抗を考慮すると少ない程よく、こ
れらからして2〜10゜、特に2〜7゜が好適である。
なお、第6図に示されているようにこの金属内針
にもその基端部にはハブ18が一体にとりつけら
れている。第3図はこの発明の他の実施例を示す
留置針の要部拡大図である。これは第2図に示し
たものと略同様であるが第2図に示したものが金
属内針の刃面形成部を折曲げているのに対し、こ
の実施例のものは、刃面形成部背面13bにわん
曲部を形成した点が相違するだけである。この場
合のわん曲は、第2図で示したものについて述べ
たと同様針先端がカテーテルと接触することを防
止し、かつ挿入時の刺通抵抗を考慮して曲率半径
1〜56mmとするのが好適である。 なお、ここでの曲率半径Rは次式で算出したも
のとする。 R=l2+m2/2m m:針先の先端から刃面の背面の延長線上に垂
直線を下し、その交叉点までの長さ l:内針のわん曲基点から、上記のmで定義す
る交叉点までの長さ 上述した折曲部14あるいはわん曲部14′は、
刃面形成部13のうち、先端から30〜70%の個所
で折曲げあるいはわん曲させる。折曲げあるいは
わん曲部が刃面形成部のうち先端から上記限定の
範囲末満であると使用時の刺通抵抗が大きくな
る。またこの範囲を超えると折曲げに大きな力を
加えなければならない外、折曲げ時に金属管が破
損するおそれがある。 〔留置針の製造方法〕 まずカテーテル11についていえば、原料とし
て前述した如きETFE、FEPといつた合成樹脂を
押出し成形で所定のパイプ形状に押出し、これを
所定の長さにカツトし、基端部にハブを取りつけ
製造するが、ここに於ける製法は従来における方
法がそのまま採用される。 一方、金属内針12は、ステンレスの金属素管
を切断、研削してこれにあらかじめ傾斜角度16〜
20゜の刃面形成部13を形成し、さらにバリ取り
処理、洗浄、乾燥といつた処理を施す。その後こ
れの刃面形成部13の背面13bを中心軸方向に
折曲げまたはわん曲させる。この折曲げまたはわ
ん曲には第4図および第5図に示す特殊な装置が
用いられる。まず第4図から説明すれば、この装
置は固定台15、可動台16押圧部材17とから
なつていて、固定台15の上に予め刃面の形成さ
れた金属内針12を載置する。固定台15の表面
には載置用の、例えばV溝15aが設けられてい
て、ここに金属内針12を載置する。可動台1
6、前記の固定台15と対向して設けられ、図示
しない装置で固定台15との間隔を任意に調節で
きるようになつている。可動台16は、図示する
ように下端面に角部が形成されてあつて、その偶
角部で位置決め16aされるようになつている。
押圧部材17は、その上端面を固定台15と平行
な平面で配設され、固定台15と同様上端面に例
えばV溝17aが設けられている。この押圧部材
17は、図示しない機構で上方に押し上げられる
ようになつている。この装置を用いて金属内針1
2を折曲げるには、まず固定台15と可動台17
との間を所定間隔にセツトしたのち、この間に金
属内針12の刃面形成部13を挿入する。この場
合、刃面13aを可動台16の方向に向けて挿入
すると、可動台17の位置決め部16aにこの刃
面の一部がつき当り、これでもつて金属内針12
の挿入位置が正確に定められる。この状態で押圧
部材17を図示しない機構を作動させて押し上げ
る。するとこの押圧部材はまず刃面形成部13の
背面13bに接触し、更にこれを押し上げて背面
13bを中心軸方向に折曲げることになる。すな
わち刃面尖鋭部13cが管状内針12の外壁延長
線20の内側に位置することとなる。 上述の折曲げ加工に際し、金属内針12の挿入
位置の調節は、可動台16は上下に調節すること
によつて行なわれる。この場合、可動台の位置決
め部16aと接する金属内針12の個所は、ここ
を支点として折曲げられることになる。その個所
はすでにのべたように、刃面形成部13の先端か
ら30〜70%の個所がとする。また、折曲げ角度
も、上述した折曲げ部14を得るために2〜10゜
とする。なお、本発明において刃面形成部13の
背面13bをわん曲とするには、例えば第5図に
示すように押圧部材17の上端を円弧状とし、こ
の押圧部材17で背面13bを押上げることによ
つて行なわれる。 こうして得られた金属内針12は、その後これ
をカテーテル11内に挿通して本発明になる留置
針が製造され、これがそのまま通常の使用形態に
供される。 発明の具体的効果 〔留置針〕 (1) この発明にある留置針として、例えば刃面形
成部13の背面が 折曲部の長さ 0.8〜1.5mm 折曲角度 2.0〜6.0゜ またカテーテル:材質 ETFE 内径 0.91〜1.01mm 外径 12.7〜1.37mm 長さ 64mm 先端の内径 0.86mm として、上記金属内針をカテーテル内に挿通し
て本発明に係る留置針を従来の通常のラインに
のせたところ、不良品の発生率は3%と少なか
つた。 これに対し折曲部のない従来の金属内針を用い
てカテーテル内に挿通したものは、前記と同様通
常の製造ラインにのせたところ不良率が10%と高
かつた。 また本発明に係る金属内針は、刺通抵抗が12.8
gで従来のもの(刺通抵抗15.0g)より、刺通抵
抗はやや小さかつた。 〔留置針の製造方法〕 また本発明製造方法によれば、金属内針12を
固定台15と可動台16との間に挿入するだけで
傾斜した刃面13bが位置決め部16aに当つて
挿入位置が固定される。従つて留置針の大きさに
応じて可動台16の上下位置を調節するだけで任
意の位置に位置決めでき、操作が簡単であるとと
もに装置が単純であり、また折曲げ部14の角度
のばらつきが少ない。 また、折曲げに際して背面13bの折曲げ角度
が2〜10゜、湾曲に際して背面13bの湾曲度が
曲率半径1mm〜56mmとし、更に先端から30〜70%
の範囲について折曲げあるいは湾曲すれば、大き
な力を必要とせずに操作をおこなうことができ刃
面形成部13の幅が広がつたり亀裂、破損が生じ
ることがなく、製品の歩留が向上する。 本発明方法によれば上述の如く折曲角度のばら
つきが少なく亀裂、破損がないが、このことは下
記の実験例で確認された。 実験例 金属内針:外径0.88〜0.91mm、内径0.59mm、刃
面形成部の長さ2.59〜3.04mm、傾斜角度
18゜、 この金属内針280本を第4図に示す装置を用い
て、折曲部が先端から0.8〜1.5mmの個所でその折
曲角度が4.0゜程度となるように折曲げた。折曲げ
後、投影機で折曲げ角度を測定し、その結果を第
1表に示す。
The catheter 11 is made of a synthetic resin, such as ethylene tetrafluoroethylene (ETFE) or fluorinated ethylene propylene (FEP), and is usually integrally molded by extrusion molding. This catheter 11 has a tip portion 11a with a small inner diameter and a tapered outer diameter. The inner diameter of the catheter varies depending on the type, but is usually 0.57~
It is 1.78mmφ. Note that a hub 18 is integrally attached to the proximal end of this catheter. On the other hand, the metal inner needle 12 is formed of stainless steel into a cylindrical shape, and a blade surface forming part 13 is provided at the tip thereof, and a blade surface 13a is attached to this blade surface forming part 13. The blade surface 13a is normally an inclined surface of 16 to 20 degrees,
Further, both sides of the blade surface 13a of the blade surface forming portion 13 are shaved at a portion 30 to 70% of the length from the tip to make the tip sharp. Further, in this metal inner needle 12, the back surface 13b of the blade surface forming portion 13 is bent in the central axis direction. This bent portion 14 is
The tip of the blade surface forming part 13 is the inner wall of the catheter 11,
In particular, it is provided so that it does not touch the inner wall of the tip 11a, and from this point of view, the larger the bending angle (α) is, the better, but on the other hand, when considering the penetration resistance when inserting this needle into the body during use, The smaller the better, and 2 to 10°, particularly 2 to 7°, is preferred.
As shown in FIG. 6, a hub 18 is also integrally attached to the base end of this metal inner needle. FIG. 3 is an enlarged view of the main parts of an indwelling needle showing another embodiment of the present invention. This is almost the same as the one shown in Figure 2, but while the blade face forming part of the metal inner needle is bent in the one shown in Figure 2, the blade face forming part of this example is bent. The only difference is that a curved portion is formed on the back surface 13b. In this case, the radius of curvature should be 1 to 56 mm to prevent the needle tip from coming into contact with the catheter and to take into account the penetration resistance during insertion, as described for the case shown in Figure 2. suitable. Note that the radius of curvature R here is calculated using the following formula. R = l 2 + m 2 / 2 m m: Draw a vertical line from the tip of the needle tip to the extension line of the back of the blade surface, and the length to the intersection point l: From the curvature base point of the inner needle to the above m Length to defined intersection point The above-mentioned bent portion 14 or curved portion 14' is
The blade surface forming portion 13 is bent or curved at 30 to 70% from the tip. If the bent or curved portion extends beyond the above-mentioned range from the tip of the blade surface forming portion, the piercing resistance during use will increase. Moreover, if it exceeds this range, not only will it be necessary to apply a large force to the bending process, but there is a risk that the metal tube will be damaged during the bending process. [Method for manufacturing the indwelling needle] First, regarding the catheter 11, synthetic resins such as ETFE and FEP as mentioned above are extruded as raw materials into a predetermined pipe shape, cut into a predetermined length, and the proximal end is extruded into a predetermined pipe shape. The hub is attached to the part and manufactured, and the manufacturing method used here is the same as the conventional method. On the other hand, the metal inner needle 12 is made by cutting and grinding a stainless steel metal tube and pre-setting it at an inclination angle of 16 to 16.
A 20° blade surface forming portion 13 is formed, and further treatments such as deburring, cleaning, and drying are performed. Thereafter, the back surface 13b of the blade surface forming portion 13 is bent or curved in the direction of the central axis. Special equipment is used for this bending or curving, as shown in FIGS. 4 and 5. First, referring to FIG. 4, this device is composed of a fixed base 15, a movable base 16, and a pressing member 17. On the fixed base 15, a metal inner needle 12 with a blade surface previously formed is placed. For example, a V-groove 15a for placement is provided on the surface of the fixing base 15, and the metal inner needle 12 is placed here. Movable stand 1
6. It is provided opposite the fixing base 15, and the distance between the fixing base 15 and the fixing base 15 can be arbitrarily adjusted using a device not shown. As shown in the figure, the movable table 16 has a corner formed on its lower end surface, and is positioned 16a by the even corner.
The pressing member 17 has its upper end surface parallel to the fixing base 15 and is disposed in a plane parallel to the fixing base 15, and similarly to the fixing base 15, the upper end surface is provided with, for example, a V-groove 17a. This pressing member 17 is adapted to be pushed upward by a mechanism not shown. Using this device, the metal inner needle 1
2, first bend the fixed base 15 and the movable base 17.
After setting a predetermined interval between the two, the blade surface forming portion 13 of the metal inner needle 12 is inserted between the two. In this case, when the blade surface 13a is inserted toward the movable table 16, a part of this blade surface hits the positioning part 16a of the movable table 17, and this also prevents the metal inner needle 12 from being inserted.
The insertion position is accurately determined. In this state, the pressing member 17 is pushed up by operating a mechanism (not shown). Then, this pressing member first comes into contact with the back surface 13b of the blade surface forming portion 13, and further pushes it up to bend the back surface 13b in the direction of the central axis. That is, the blade surface sharp portion 13c is located inside the outer wall extension line 20 of the tubular inner needle 12. During the above-mentioned bending process, the insertion position of the metal inner needle 12 is adjusted by vertically adjusting the movable table 16. In this case, the portion of the metal inner needle 12 that contacts the positioning portion 16a of the movable base is bent using this portion as a fulcrum. As already mentioned, the location is 30 to 70% from the tip of the blade surface forming portion 13. Further, the bending angle is also set to 2 to 10 degrees in order to obtain the above-mentioned bent portion 14. In the present invention, in order to make the back surface 13b of the blade surface forming part 13 curved, for example, as shown in FIG. It is carried out by. The metal inner needle 12 thus obtained is then inserted into the catheter 11 to produce the indwelling needle of the present invention, which is then put to normal use as it is. Specific Effects of the Invention [Indwelling Needle] (1) As the indwelling needle according to the present invention, for example, the back surface of the blade surface forming part 13 has a bending part length of 0.8 to 1.5 mm, a bending angle of 2.0 to 6.0°, and a catheter: material. ETFE Inner diameter 0.91~1.01mm Outer diameter 12.7~1.37mm Length 64mm Inner diameter of tip 0.86mm When the above metal inner needle was inserted into the catheter and the indwelling needle according to the present invention was placed on the conventional normal line, The incidence of defective products was as low as 3%. On the other hand, when a conventional metal inner needle without a bent part was inserted into a catheter, the defect rate was as high as 10% when it was put on a normal manufacturing line as described above. Furthermore, the metal inner needle according to the present invention has a piercing resistance of 12.8
The piercing resistance was slightly smaller than the conventional one (piercing resistance 15.0 g). [Manufacturing method of indwelling needle] Furthermore, according to the manufacturing method of the present invention, by simply inserting the metal inner needle 12 between the fixed base 15 and the movable base 16, the inclined blade surface 13b hits the positioning part 16a and the insertion position is adjusted. is fixed. Therefore, it is possible to position the indwelling needle at any position by simply adjusting the vertical position of the movable base 16 according to the size of the indwelling needle, and the operation is simple and the device is simple. few. Also, when bending, the bending angle of the back surface 13b is 2 to 10 degrees, and when bending, the degree of curvature of the back surface 13b is 1 mm to 56 mm, and the radius of curvature is 30 to 70% from the tip.
If the blade is bent or curved in the range of , the operation can be performed without requiring a large force, and the width of the blade surface forming part 13 will not expand, cracks or damage will occur, and the product yield will be improved. do. According to the method of the present invention, as described above, there is little variation in the bending angle and there is no cracking or damage, and this was confirmed in the following experimental examples. Experimental example Metal inner needle: outer diameter 0.88 to 0.91 mm, inner diameter 0.59 mm, blade surface forming part length 2.59 to 3.04 mm, inclination angle
Using the device shown in FIG. 4, 280 of these metal inner needles were bent so that the bending angle was approximately 4.0° at a point 0.8 to 1.5 mm from the tip. After bending, the bending angle was measured using a projector, and the results are shown in Table 1.

【表】 また刃面につき顕微鏡で観察した結果、刃面び
刃面裏面に僅かに光沢の変化が見られたが、きず
ではなく刺通上の問題は全くないことがわかつ
た。また刃先のツブレ等の問題もなかつた。
[Table] Furthermore, as a result of microscopic observation of the blade surface, a slight change in gloss was observed on the blade surface and the back surface of the blade, but it was found that this was not a flaw and there was no problem with piercing. There were also no problems with the blade tip becoming cracked.

【図面の簡単な説明】[Brief explanation of drawings]

第1図は従来の留置針の断面図、第2図及び第
3図は本発明のそれぞれ異なる実施例を示す留置
針の断面図、第4図及び第5図は本発明方法に用
いるそれぞれ異なる折曲げ装置の断面図、第6図
は、本発明の留置針を金属内針をカテーテルから
取外した状態を示す斜視図である。 11……カテーテル、12……金属内針、13
……刃面形成部、13a……刃面、13b……背
面、14……折曲げ部(湾曲部)、15……固定
台、16……可動台、17……押圧部材、18…
…ハブ。
Fig. 1 is a sectional view of a conventional indwelling needle, Figs. 2 and 3 are sectional views of indwelling needles showing different embodiments of the present invention, and Figs. 4 and 5 are different sectional views of indwelling needles used in the method of the present invention. FIG. 6 is a cross-sectional view of the bending device, and is a perspective view showing the indwelling needle of the present invention with the metal inner needle removed from the catheter. 11...Catheter, 12...Metal inner needle, 13
...Blade surface forming portion, 13a...Blade surface, 13b...Back surface, 14...Bending portion (curved portion), 15...Fixed base, 16...Movable base, 17...Press member, 18...
…Hub.

Claims (1)

【特許請求の範囲】 1 基端にハブを備え先端にその背面を中心軸方
向に折曲げまたはわん曲した刃面を形成し、折曲
げまたはわん曲する箇所を刃面のうち先端から30
〜70%の範囲としてなる管状金属内針を、基端部
にハブを備えた合成樹脂製カテーテルに挿通し、
このカテーテル開口部から上記金属内針の刃面形
成部を突出せしめてなる留置針。 2 折曲げた刃面の背面の折曲げ角度を2〜10゜
とした特許請求の範囲第1項記載の留置針。 3 わん曲した刃面の曲率半径を1〜56mmとした
特許請求の範囲第1項記載の留置針。 4 基端においてハブを備えてなる管状内針にあ
らかじめ刃面を形成し、この刃面を表面に溝を設
けた固定台と管状内針の挿入位置調節自在な可動
台との間に挿入固定し、しかるのち刃面尖鋭部が
管状内針の外壁延長線の内側に位置するように押
圧部材で刃面の背面から管状内針の中心軸方向に
折曲げまたはわん曲し、折曲げまたはわん曲する
箇所を刃面のうち先端から30〜70%の範囲とし、
ここに得られた管状内針を管状内針より短く基端
においてハブを備えてなるとともに少なくとも先
端において管状内針をその外周面と接する合成樹
脂製カテーテルに挿通することを特徴とした留置
針の製造方法。 5 折曲げる刃面の折曲げ角度を2〜10゜とする
特許請求の範囲第4項記載の留置針。 6 わん曲にする刃面のわん曲度を曲率半径を1
〜56mmとする特許請求の範囲第4項記載の留置針
の製造方法。
[Claims] 1. A hub is provided at the base end, and a blade surface is formed at the tip with its back surface bent or curved in the direction of the central axis, and the portion of the blade surface to be bent or curved is located 30 minutes from the tip of the blade surface.
A tubular metal-inner needle with a diameter of ~70% is inserted into a synthetic resin catheter with a hub at the proximal end.
An indwelling needle comprising a blade surface forming portion of the metal inner needle protruding from the catheter opening. 2. The indwelling needle according to claim 1, wherein the bending angle of the back surface of the bent blade surface is 2 to 10 degrees. 3. The indwelling needle according to claim 1, wherein the curved blade surface has a radius of curvature of 1 to 56 mm. 4 A blade surface is formed in advance on a tubular inner needle having a hub at the base end, and this blade surface is inserted and fixed between a fixed base with a groove provided on the surface and a movable base that can freely adjust the insertion position of the tubular inner needle. Then, the blade surface is bent or curved from the back surface of the blade surface in the direction of the central axis of the tubular inner needle using a pressing member so that the sharp part of the blade surface is located inside the outer wall extension line of the tubular inner needle. The bending area should be within 30-70% of the blade surface from the tip.
An indwelling needle characterized in that the tubular inner needle obtained herein is shorter than the tubular inner needle and is provided with a hub at the proximal end, and the tubular inner needle is inserted at least at the distal end into a synthetic resin catheter in contact with the outer peripheral surface of the tubular inner needle. Production method. 5. The indwelling needle according to claim 4, wherein the bending angle of the blade surface is 2 to 10 degrees. 6 Set the radius of curvature to 1 for the degree of curvature of the blade surface to be curved.
The method for manufacturing an indwelling needle according to claim 4, wherein the indwelling needle has a diameter of 56 mm.
JP10448480A 1980-07-30 1980-07-30 Detained neeld and its manufacture Granted JPS5729366A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP10448480A JPS5729366A (en) 1980-07-30 1980-07-30 Detained neeld and its manufacture

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP10448480A JPS5729366A (en) 1980-07-30 1980-07-30 Detained neeld and its manufacture

Publications (2)

Publication Number Publication Date
JPS5729366A JPS5729366A (en) 1982-02-17
JPS6411311B2 true JPS6411311B2 (en) 1989-02-23

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Family Applications (1)

Application Number Title Priority Date Filing Date
JP10448480A Granted JPS5729366A (en) 1980-07-30 1980-07-30 Detained neeld and its manufacture

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JP (1) JPS5729366A (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS58144926A (en) * 1982-02-23 1983-08-29 Matsushita Electric Ind Co Ltd Controlling system of power supply
JPS58144925A (en) * 1982-02-23 1983-08-29 Matsushita Electric Ind Co Ltd Controlling system of power supply
JPS58144928A (en) * 1982-02-23 1983-08-29 Matsushita Electric Ind Co Ltd Controlling system of power supply
JP7351843B2 (en) * 2018-09-19 2023-09-27 テルモ株式会社 catheter assembly

Also Published As

Publication number Publication date
JPS5729366A (en) 1982-02-17

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